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Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
B7-DC cross-linking antibody rHIgM12B7
flow cytometry
immunologic technique
laboratory biomarker analysis
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma

    • Stage IV disease (M1a and M1b only)
  • Measurable disease according to RECIST criteria
  • HLA-A2 positive
  • Must have IgA in serum (any concentration)
  • No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Hemoglobin ≥ 10.0 g/dL
  • Platelet count ≥ 75,000/mm^3
  • AST ≤ 5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to provide informed consent
  • Agrees to return to Mayo Clinic Rochester for follow-up
  • Agrees to participate in the mandatory translational research component of the study
  • No uncontrolled or current infection
  • No known immune deficiency
  • No B or AB blood grouping

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy and recovered
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunosuppressive therapy

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Secondary Outcome Measures

Progression free survival and overall survival time
Toxicity
Tumor response in terms of complete or partial response at 8 weeks
Tetramer response
Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components

Full Information

First Posted
April 12, 2008
Last Updated
May 23, 2017
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00658892
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Official Title
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 8, 2008 (Actual)
Primary Completion Date
February 15, 2010 (Actual)
Study Completion Date
May 22, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Detailed Description
OBJECTIVES: Primary Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma. Secondary Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients. Determine the treatment impact on tumor growth (e.g., objective response, time to progression). OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1. Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry. After completion of study treatment patients are followed every 2 months for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
B7-DC cross-linking antibody rHIgM12B7
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
immunologic technique
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Secondary Outcome Measure Information:
Title
Progression free survival and overall survival time
Title
Toxicity
Title
Tumor response in terms of complete or partial response at 8 weeks
Title
Tetramer response
Title
Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage IV disease (M1a and M1b only) Measurable disease according to RECIST criteria HLA-A2 positive Must have IgA in serum (any concentration) No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin ≥ 10.0 g/dL Platelet count ≥ 75,000/mm^3 AST ≤ 5 times upper limit of normal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to provide informed consent Agrees to return to Mayo Clinic Rochester for follow-up Agrees to participate in the mandatory translational research component of the study No uncontrolled or current infection No known immune deficiency No B or AB blood grouping PRIOR CONCURRENT THERAPY: More than 4 weeks since prior chemotherapy and recovered More than 4 weeks since prior biologic therapy No concurrent immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetomir Markovic, M.D., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

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